{"schema_version":"secwatch.filing_event.v1","accession":"0001438533-26-000005","form_type":"8-K","ticker":"TVTX","cik":"0001438533","company_name":"Travere Therapeutics, Inc.","filed_at":"2026-01-13T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.090442+00:00","generated_at":"2026-05-16T10:38:50.858870+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"FDA extends FILSPARI FSGS sNDA PDUFA to April 13, 2026; cites Major Amendment","bullets":["FDA extended PDUFA target action date to April 13, 2026, after determining supplemental NDA responses constitute a Major Amendment.","No safety or manufacturing concerns raised; FDA requested additional characterization of FILSPARI's clinical benefit in FSGS.","If approved, FILSPARI would be the first FDA-approved pharmacologic therapy for focal segmental glomerulosclerosis (FSGS).","Phase 3 DUPLEX study missed primary eGFR slope endpoint but showed proteinuria reduction and lower end-stage kidney disease rate vs irbesartan."],"urls":{"canonical":"https://secwatch.observer/filing/0001438533-26-000005","json":"https://secwatch.observer/filing/0001438533-26-000005.json","markdown":"https://secwatch.observer/filing/0001438533-26-000005.md","text":"https://secwatch.observer/filing/0001438533-26-000005.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1438533/000143853326000005/0001438533-26-000005-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1438533/000143853326000005/tvtx-20260113.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T10:38:50.858870+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}